A conventional “virtual data room” (VDR) (also, referred to as a “virtual deal room”) is an online repository of information that is used to store and distribute documents that need to be shared and disclosed among different entities. A VDR is often used to facilitate the due diligence process during financial transactions, such as a merger and acquisition transaction, or when an entity is deciding whether to make an investment in a company. The VDR replaces a physical data room that previously housed the repository of information, typically in paper form. In a VDR, the documents are stored in electronic format on a central server and accessed via the Internet. VDRs are assumed to be secure and confidential and a login ID and password is typically required to access the VDR. There are dozens of companies that host VDRs such as Merrill Corporation which provides the Merrill DataSite®.
A clinical data management system or CDMS is used in clinical research to manage the data of a clinical trial. The clinical trial data includes patient data collected at investigator sites in case report forms (CRFs) and patient data received back from patient samples sent to labs. The data that resides in a database associated with a CDMS must be protected in many ways, including protection from access by unauthorized persons.
The life science industry has begun to use VDRs for a variety of purposes other than conventional M&A due diligence. For example, VDRs are used by sponsors to allow potential investors and potential licensees to view documents related to clinical trials. Nonetheless, there is still a need in the art to provide additional functionality in VDRs that are used for these purposes, including the ability to view reports generated on-the-fly from real-time clinical data of an ongoing clinical trial study that resides in a CDMS and to allow the host of the VDR to easily control the availability of such reports to users logged into the VDR. The present invention fulfills such needs.